Immunogenicity Study of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

March 31, 2020 updated by: Dr Tri Juli Edi Tarigan, SpPD-KEMD, Indonesia University

Open Label Randomized Multicenter Clinical Trial to Compare Immunogenicity of Insulin Glargine Ezelin vs Lantus in Type 2 Diabetes Mellitus Patients

This is an open-label randomised multicenter clinical study to compare immunogenicity of the drug products Insulin Glargine (Kalbe Farma) and Lantus (Sanofi -Aventis) in type 2 diabetes mellitus patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous study has revealed that Insulin Glargine (Kalbe Farma) has similar efficacy with Lantus (Sanofi-Aventis) in controlling blood glucose in type 2 diabetes mellitus patients, but the immunogenicity potential of this product has not been known. Therefore, the present study is aiming to compare immunogenicity of Insulin Glargine (Kalbe Farma) and Lantus (Sanofi-Aventis) in type 2 diabetes mellitus patients in an open-label randomised multicenter clinical study.

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10520
        • Department of Internal Medicine Cipto Mangunkusumo Hospital, Faculty of Medicine Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women, 18 years old and above
  • Diabetes mellitus type 2 patients who has failed an oral hypoglycemic drug products, insulin-naive, disease duration of at least 6 months, inadequate glycemic control (HbA1c > 7.0 %)
  • BMI ranged from 19 - 35 kg/m2
  • Consent from patients of childbearing potential to use contraception method throughout the study
  • Signed informed consent form

Exclusion Criteria:

  • History of diabetic ketoacidosis more than 2 times in the past 1 year
  • History of pancreatectomy
  • Estimated glomerular filtration rate <30 mL/min
  • Positive ZnT8 Antibody
  • Treatment with glucocorticoids, immunodepressant or cytostatics in 60 days before study.
  • Any malignant disease, including in medical history
  • Drugs and alcohol abuse, including in medical history
  • Hipersensitivity to insulin glargine or any excipient of the drugs from medical history
  • Mental disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin Glargine Ezelin
Drug product Insulin Glargine, Ezelin 100 U/mL (PT Kalbe Farma, Tbk)
Drug: Insulin Glargine Ezelin
Insulin Glargine (Ezelin) once daily at individually adjusted dose
Other Names:
  • Ezelin
Active Comparator: Insulin Glargine Lantus
Insulin Glargine Pen Injector [Lantus]
Drug: Insulin Glargine Pen Injector [Lantus]
Insulin Glargine (Lantus) once daily at individually adjusted dose
Other Names:
  • Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of immune response
Time Frame: 6 months
Production of antibodies against insulin /IAA and ZnT8 antibody in investigational drug product and comparator groups
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 months
change in HbA1c level after 6 months of therapy compared to baseline value
6 months
Fasting blood glucose
Time Frame: 6 months
Change in fasting blood glucose
6 months
Hypoglycemia
Time Frame: 6 months
Incidence and severity of hypoglycaemia cases
6 months
Adverse events
Time Frame: 6 months
Incidence and severity of adverse events
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Tri Juli Edi Tarigan, MD, Cipto Mangunkusumo Hospital/Faculty of Medicine Universities Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 14, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaU-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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